A Cutting Edge Of Controversy A Cutting Edge Of Controversy Doctors Disagree On Safety Of Artery-clearing Device

October 06, 1992|by ANN WLAZELEK, The Morning Call

It looks like a miniature football and spins faster than one of Randall Cunningham's tosses -- up to 190,000 revolutions per minute.

But then the device, a new surgical tool called a Rotablator, must cut through tougher stuff than air. Its job is to bore a smooth hole through hardened plaque inside arteries.

Dr. Geoffrey Toonder, a Lehigh Valley cardiovascular surgeon, has used the Rotablator to open arteries in the legs of 10 local patients and believes the device shows such promise that it may someday be approved for coronary arteries as well.

But several other area surgeons fear the Rotablator will clog more arteries than it opens. Based on study results, they say the Rotablator is one reason patients and referring physicians should not rush out to try the newest devices and procedures.

The jury will be out indefinitely, however, because the manufacturer, Heart Technology of Bellevue, Wash., has voluntarily recalled an estimated 10,000 Rotablators being used in the United States.

The action was taken this summer following reports that three of the devices malfunctioned during experimental coronary artery surgery.

Surgery was successfully completed on three of the five patients in which the tool malfunctioned before the malfunction was detected, said company spokesman Bill Scott.

But for the other two, bypass surgery had to be performed, and one patient later died, he said. None of the malfunctions had to do with leg surgery, Scott added, but surgeons were asked to return the Rotablators for replacements.

The U.S. Food and Drug Administration cleared the Rotablator for marketing as a device that removes plaque from arteries in the extremities on Sept. 14, 1990.

An outside panel of experts also has recommended the Rotablator be approved for coronary arteries, but with conditions, said FDA spokeswoman Sharon Snider.

The FDA has not acted on that recommendation. But after using the Rotablator on 10 patients at Allentown Osteopathic Medical Center since February, Toonder said the Rotablator appears safer and more effective than the balloon catheter for opening clogged leg vessels.

"I think it may replace or be used in conjunction with the balloon," Toonder said, noting the Rotablator appears to cause less trauma to the blood vessel than the balloon, which often cracks and tears the artery wall when it inflates.

Toonder said he had no problems with the Rotablator he used.

Other area heart and vascular surgeons, however, reported serious reservations about the device. They believe the Rotablator, like lasers, has been shown to be less effective than bypass surgery and perhaps more dangerous.

Studies have shown that blockages return at a higher rate after the use of Rotablators or balloons because of the damage to the artery lining, said Dr. Alan Berger, chief of the vascular surgery division at Lehigh Valley Hospital (LVH).

"We're not considering the use of a Rotablator at this time," he said. "Basically, it's still an experimental tool."

In one significant study of the device on leg arteries, Dr. Wesley Moore of the UCLA School of Medicine, Los Angeles, found complications that included a cut in an artery's inner lining, two equipment breaks, minor blood clots, major blood clots resulting in skin loss, blood in the urine, wound infection and limb loss.

At six months, 66 percent of the arteries of the 20 patients studied remained open, but the rate dropped to 12 percent at two years, the study showed.

Because of the blood clots, vessel damage and low long-term success rate, the study's principal investigators concluded that rotablation "is not recommended for general use" until the problems are solved.

But Toonder cited another study, done at St. Luke's Medical Center in Milwaukee, in which the Rotablator opened clogged arteries in the legs of 38 of 43 patients, for a 95 percent success rate.

The risk of blood in the urine and blood clots at entry site were "not negligible," according to the researchers. But, according to Toonder, they can be controlled by technique.

Berger said LVH would be willing to look at Toonder's results, but the hospital would not add the Rotablator to its surgical tool supply until there is proof of its effectiveness.

"We are conservative here," he said. "We want to know that it's better than what we have before we take it out to the general public. Not everyone wants what's investigational."

The Rotablator is one of a number of technical advances that have been developed to remove plaque from arteries, added Dr. James Balshi, a vascular surgeon whose group serves St. Luke's and Easton hospitals.

"Some cut, some pulverize and some incorporate the laser, the balloon and suction," he said. "All are looking for a real substantial benefit, but I'm not sure we've seen that yet."

The problem, area vascular surgeons agreed, is that almost anything can damage the onion-skin-thin lining of the blood vessel and cause it to build new blockages by laying down scar tissue.